In mid-2014, state survey agencies and CMS piloted a short-term focused survey in five states to assess nursing home Minimum Data Set, Version 3.0 (MDS 3.0) coding practices and its relationship to resident care. According to a CMS memo to state survey agencies, these surveys enhanced surveyors’ ability to identify errors and deficiencies, such as inaccuracies related to staging and documentation of pressure ulcers, the classification of antipsychotic drugs, and coding regarding the use of restraints. CMS therefore announced that it plans to expand these surveys nationwide in 2015. The scope of some or all of the focused surveys also will be expanded to include an assessment of the staffing levels of nursing facilities. Specifically, the assessment is intended to verify the staffing data self-reported by the nursing home and identify changes in staffing levels throughout the year.
CMS has announced that the CY 2015 Medicare outpatient therapy limit is $1,940 for physical therapy and speech-language pathology combined and $1,940 for occupational therapy. The therapy cap exceptions process was extended through March 31, 2015 by the Protecting Access to Medicare Act of 2014.
CMS has announced that it is delaying until further notice enforcement of its regulations pertaining to health plan enumeration and use of the Health Plan Identifier (HPID) in HIPAA transactions, which were adopted in a September 5, 2012 final rule. This enforcement delay, which is effective October 31, 2014, applies to all HIPAA covered entities, including healthcare providers, health plans, and healthcare clearinghouses. This enforcement discretion period will allow HHS to consider recent recommendations by the National Committee on Vital and Health Statistics (NCVHS) that covered entities not use the HPID in the HIPAA transactions.
This post was written by Vicki Morris.
The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance, entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” follows the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which added a provision (and teeth) to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that render a drug “adulterated” – a new term used by the FDA in this context. Specifically, a drug adulterated under FDASIA “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” FDA issued the revised guidance in response to comments on the Agency’s draft guidance for industry of the same title issued in July 2013.
The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection, as discussed below.Continue Reading...
CMS has announced its newest innovative delivery reform program, called the “Transforming Clinical Practice Initiative,” which will provide up to $840 million over four years to help clinicians share, adapt, and develop quality improvement strategies. CMS intends to make awards for the following two types of systems:
- Practice Transformation Networks are peer-based learning networks designed to help clinicians develop core competencies specific to practice transformation. CMS is seeking applicants that have pre-existing relationships with multiple clinician practices that include data sharing capabilities (e.g., health systems; regional extension centers; quality improvement organizations; large group practices; regional/state-based health collaboratives; and hospital systems).
- Support and Alignment Networks will promote workforce development through organizations that use tools such as continuing medical education, maintenance of certification, and core competency development to help ensure sustainability of these efforts. Applicants could include medical professional associations, specialty societies, and organizations that generate evidence-based clinical practice guidelines, support efforts to reduce unnecessary testing and procedures, and effectively incorporate safety and patient/family engagement.
Applicants are encouraged to submit a letter of intent by November 20, 2014, and applications are due by January 6, 2015. CMS anticipates announcing awards in spring/summer 2015.
CMS has announced a new Accountable Care Organization “Investment Model” that was developed in response to concerns that some providers lack adequate access to the capital needed to invest in infrastructure necessary to successfully implement population care management. CMS will provide as much as $114 million in upfront investments to up to 75 ACOs across the country to help these ACOs make infrastructure investments and develop new ways to improve care for Medicare beneficiaries.
CMS is inviting quality measure suggestions for potential use in the Physician Quality Reporting System (PQRS) and other physician quality programs. Measure suggestions will be accepted on an ongoing basis, with measures submitted prior to June 15, 2015 eligible to be considered for inclusion in the PQRS as early as 2017.
CMS has posted the 2015 Medicare Star Ratings for Medicare Advantage (MA) and Medicare Part D prescription drug plans (PDPs). According to a CMS fact sheet, there are increases in the number of Medicare beneficiaries in high-performing MA plans and PDPs for 2015, while CMS notes “dramatic improvement” among plans that had received the low performing icon in 2014. CMS also is interested in receiving information from the public regarding potential data differences in MA and Part D quality measurements for dual-eligible versus non-dual-eligible enrollees. Information is due November 3, 2014. Finally, CMS has released the MA and PDP annual audit and enforcement report for 2013. According to the report, CMS imposed 43 CMPs totaling almost $8.4 million on 39 different organizations and 5 cases of immediate suspension of enrollment and marketing activities for issues identified in 2012 and 2013. Most violations cited in enforcement actions related to inappropriate delays or denials of access to health services and medications for enrollees.
As previously reported, CMS is offering an "administrative agreement" providing partial payment to hospitals that drop their appeals related to certain short-stay hospital claims in an effort to reduce the backlog in Medicare appeals. CMS has posted updated “frequently asked questions” on its proposed settlement process. The deadline for applying for the settlement is October 31, 2014, but providers may request an extension if they are not able to meet this deadline.
CMS has released a beta version of its Open Payments search tool, which is intended to facilitate public review of payments and transfers of value made by drug and device manufacturers and group purchasing organization (GPOs) to physicians and teaching hospitals, as well as physician ownership information. The tool allows the public to search identified data for physicians, teaching hospitals, or companies. CMS is also reminding applicable manufacturers and GPOs of an October 31, 2014 deadline for making corrections to any 2013 Open Payments disputed records for publication on or before December 31, 2014 (although data corrections can be performed at any time). Disputes that remain unresolved as of October 31, 2014 will display as disputed in the Open Payments database.
CMS has posted its preliminary payment determinations for new 2015 clinical laboratory fee schedule codes. The document lists CMS’s recommendation regarding the basis of payment for codes -- either crosswalk or gap-fill. Note that CMS is recommending to delay pricing various individual drug testing screening codes given “the potential for overpayment when billing for each individual drug test rather than a single code that pays the same regardless of the number of drugs that are being tested for.” Additional information about the comment and reconsideration process is available on the CMS website.
CMS has announced that it will make a series of improvements to the Nursing Home Five Star Quality Rating System, including additional quality measures, new data verification processes, and a revised quality scoring methodology. Among other things:
- CMS will add a new quality measure on antipsychotic medication use starting January 2015, and include claims-based data on re-hospitalization and community discharge rates in the future.
- CMS and states will implement focused survey inspections for a sample of nursing homes to verify staffing and quality measure information, effective January 2015.
- CMS will implement a quarterly electronic reporting system that is auditable back to payrolls to verify staffing information and allow for the calculation of staffing-related quality measures.
- CMS will strengthen requirements to ensure that states maintain a user-friendly website and complete timely, accurate nursing home inspections for inclusion in the rating system.
- CMS will revise the methodology used to calculate each facility’s quality measure rating in 2015.
Despite a series of technical problems and data disparities leading up to the launch, CMS met its schedule to release the first round of “Open Payments” data on September 30, 2014. Note that initial use of the database of financial payments made by drug and device manufacturers and group purchasing organization to physicians and teaching hospitals has been hampered by large file sizes, multiple databases, and confusing instructions. CMS has stated that it plans to launch a more user-friendly search tool later this month.
The first wave of data details 4.4 million payments valued at nearly $3.5 billion attributable to 546,000 individual physicians and almost 1,360 teaching hospitals during the last five months of 2013 (future annual updates will include 12 months of data). Because CMS identified payment records that appeared to have inconsistent physician information (e.g. a National Provider Identifier for one doctor and a license number for another) that could not be matched, CMS has temporarily “suppressed” the personally-identifiable information for those records. In fact, CMS estimates that about 40% of the records published initially are de-identified, and additional disputed data was not published, which could skew initial attempts to draw conclusions about payment patterns. CMS cautions that financial ties between manufacturers and providers “do not necessarily signal wrongdoing” or conflicts of interest, given that some relationships may lead to the development of beneficial new technologies and therapies. CMS encourages patients to discuss these financial relationships with their health care providers.
According to a new CMS report, fee-for-service (FFS) Medicare Recovery Auditors identified and corrected 1,532,249 claims for improper payments in FY 2013, representing $3.75 billion in improper payments. Of this amount, $3.65 billion was attributable to overpayments, compared to 102.4 million of the improper claims were underpayments that were repaid to providers and suppliers. According to CMS, after taking into consideration all fees, costs, and first level appeals (but not expenses related to third and fourth levels of appeal), the Medicare FFS Recovery Audit Program returned over $3.0 billion to the Medicare Trust Funds. With regard to provider type, inpatient hospital claims represented almost all overpayments (94%).
CMS Seeks Input on Potential Delivery Innovations in Medicare Part D, Medicare Advantage, & Other Programs
CMS is seeking input on initiatives to test care delivery innovations in the Medicare Part D program, Medicare and Medicaid managed care plans, and other government programs. CMS notes that while “[h]ealth plans increasingly have responded to market developments and fiscal pressures with innovations in care delivery, plan design, beneficiary and provider incentives, and network design,” adoption of such innovations has been more limited in stand-alone Medicare Prescription Drug Plans (PDP), Medicare Advantage (MA) and Medicare Advantage Prescription Drug plans (MA-PD), Medicaid managed care plans, Medigap plans, and Retiree Supplemental health plans. CMS therefore is seeking responses to a request for information (RFI) on potential of models to test innovations in these plans related to: (1) plan design, (2) care delivery, (3) beneficiary and provider incentives; and/or (4) network design.
For instance, with respect to drug plans, CMS is considering a PDP model that will test the impact of “robust medication therapy management programs and cost sharing differentials that effectively target Part D beneficiaries and will better coordinate care, manage health care costs, and improve outcomes.” CMS is likewise exploring potential initiatives to collaborate with Medigap and Retiree Supplemental plans on models to manage the care of complex, high-cost beneficiaries. CMS also may explore innovations in MA and MA-PD health plan design for Medicare beneficiaries, including:
- Value-based insurance design to incentivize beneficiaries with specific health conditions to use high-value health care services and/or providers;
- Inclusion of remote access technologies beyond what is covered by original Medicare; and
- Integration of hospice care benefits concurrently with curative care in the basic benefit package.
CMS points out that testing such models will require collaboration with health plans, states, and other stakeholders. Comments will be accepted on the RFI until November 3, 2014. The RFI does not commit CMS to contracting or making a grant award in this area.
CMS has posted its October 2014 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts that CMS will use to pay for Part B covered drugs for the fourth quarter of 2014. CMS notes that prices for the top Part B drugs decreased by 0.4% on average this quarter.
CMS has announced that the 2015 Medicare ambulance update factor for determining the payment limit for Medicare ambulance services will be 1.4%. This update reflects the a 2.1% increase in the consumer price index for all urban consumers (CPI-U), which is partially offset by a 0.7% productivity adjustment in accordance with the ACA.
In an effort to reduce the backlog in Medicare appeals related to certain short-stay hospital claims, CMS is offering an "administrative agreement" providing partial payment to hospitals that drop their appeals. Specifically, CMS would provide a payment equal to 68% of the net payable amount to acute care hospitals or critical access hospitals (CAH) willing to resolve their pending appeals (or waive their right to request an appeal) for inpatient-status claim denials with dates of admissions prior to October 1, 2013, and where the patient was not a Part C enrollee. Such denials involve services that may have been reasonable and necessary, but the contractor contends that treatment on an inpatient basis was not. A hospital may not choose to settle some claims and continue to appeal others, and certain hospitals could be excluded from participating in the settlement based on pending False Claims Act investigations. Also note that PPS-excluded hospitals are not eligible to participate in this program. CMS is encouraging eligible hospitals with such claim denials "to make use of this administrative agreement to alleviate the burden of current appeals on both the hospital and Medicare system." Hospitals should send their request for agreement by October 31, 2014 or request an extension from CMS. CMS is hosting a national provider call on September 9, 2014 to discuss the settlement process.
On August 28, 2014, CMS announced the latest changes to the deadlines associated with the Sunshine Act “Open Payments" System review and dispute process resulting from additional system down-time. Specifically, because the system will be periodically unavailable on August 30 and September 5, CMS is making the following changes to the data review and correction periods:
- Review and dispute (45 days): 7/14/2014 – 8/3/2014, 8/14/2014 – 9/10/2014
- Correction period (15 days): 9/11/2014 – 9/25/2014
CMS is still standing by its September 30, 2014 target date for public release of the data, although it remains to be seen whether continuing questions about the data integrity and the shrinking window to resolve all technical issues will permit CMS to meet this deadline.
* Note that CMS announced on September 9 that it was extending the review and dispute period for one more day, through September 11, 2014.